CE certification of medical devices
Implementation of the requirements of the Medical Device Regulation MDR
into the technical documentation
Regulatory strategy
Support in the definition of a regulatory strategy for medical devices
Identification of regulatory requirements for the intended purpose.
Product classification
Identification of applicable laws, directives and standards and other regulatory requirements such as the establishment of a quality management system according to ISO 13485
Implementation of the regulatory strategy
Building the structure of the technical documentation, listing and drafting the required documents.
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Establishment and updating of the risk management file
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Organization of design control and validation and verification documentation.
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Organization of process controls, including supplier audits
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Set up of clinical trials and preparation of clinical evaluation reports.
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Introduction of a quality management system according to ISO 13485
Preparation of technical documentation of medical devices
Support in the implementation of the requirements of the Medical Devices Regulation (MDR), Regulation (EU) 2017/745
Product description
Development documentation according to ISO 13485 /DHF, DHR, DMR
Compliance with the Essential Safety and Performance Requirements
Systematic literature search
Summary of the state of the art in science and technology
Clinical Evaluation Plan & Report
Biological Evaluation Plan & Report
Risk analyses according to ISO 14971
Setting up a Post Market Surveillance System
PMS – Plan
PMS – Report
Periodic Safety Update Report (PSUR)
